Study design

Primary study design

Secondary study design

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia

Intervention

Psychological intervention:Manualised protocol developed by Prof. Escobar et al, of the University of New Jersey, for the treatment of somatoform disorders that has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy.

Pharmacological intervention:In this group of patients, pregabalin (300 - 450 mg/day), recommended for the treatment of fibromyalgia, associated with duloxetine (60 - 120 mg/day) if there is comorbid depression, will be administered.

Treatment as usual at primary care level:This group will follow the usual treatment given at primary care level.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pregabalin, duloxetine

Primary outcome measures

The major outcome is pain catastrophising in patients with fibromyalgia. This construct will be assessed with the Spanish version of the Pain Catastrophising Scale. Assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention

Secondary outcome measures

1. The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class: administered only at baseline2. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview, a psychiatric interview extensively used for the study of somatoform disorders: administered only at baseline3. Hamilton test for Anxiety (HAM-A) and for Depression (HAM-D); assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention4. Fibromyalgia Impact Questionnaire (FIQ): the FIQ is a 10-item self-report questionnaire developed to measure the health status of fibromyalgia patients; assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention

Overall trial start date

01/09/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years, either sex2. Able to understand and read Spanish3. Fulfil criteria for primary fibromyalgia according to the American College of Rheumatology4. No previous psychological treatment5. No pharmacological treatment or acceptance to discontinue it two weeks before the onset of the study6. Signed informed consent